NuVent™ Revision Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium
研究概览
简要总结
This is a prospective, non-randomized, single-arm study designed to assess the safety and device performance of the NuVent navigation-guided balloon system for use in subjects with scarred, granulated, or previously surgically altered tissue (revision).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age.
- •Subject has chronic rhinosinusitis unresponsive to medical therapy and previous sinus surgery.
- •Subject has sinus surgery planned on at least one of the frontal, sphenoid or maxillary sinus ostia.
- •Subject has scarred, granulated or previously surgically altered tissue for which an image-guided balloon tool may be feasible, in the opinion of the Investigator.
- •Subject is willing and able to comply with protocol requirements.
排除标准
- •Subject is pregnant or breastfeeding.
- •Subject is not healthy enough to undergo endoscopic sinus surgery based on the opinion of the Investigator.
- •Subject has sinonasal tumors.
- •Subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint.
- •Subject lacks capacity to consent to participation in this research himself/herself.
结局指标
主要结局
Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium
时间窗: At time of surgery
Two-fold endpoint: Investigator-assessment regarding the number of sinuses that were easily navigated to the desired treatment location and easy dilation of the ostium
Device-related Adverse Event Point Estimate
时间窗: 2 weeks
The primary safety endpoint was the point estimate (and confidence interval) for all AEs that were directly attributable to the device or for which the cause could not be determined and that met the definition of designated primary safety endpoint AEs as defined in the protocol.
次要结局
- Device Safety Profile as Measured by the Overall Adverse Event Rate(2 weeks)